Postmenopausal SyndromePhase 3NCT01429662
Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women
A Phase 3 study testing Modified Relaxation (MR) and Lifestyle Education (LE) in people with Postmenopausal Syndrome and Hypertension, run by Chiang Mai University at 1 site in Thailand.
Trial summary
The purpose of this study is to demonstrate better effectiveness of modified relaxation (MR) technique over no MR for treating hypertension in Thai postmenopausal women. Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Postmenopausal Syndrome, Hypertension
- What is being tested?
- Modified Relaxation (MR) and Lifestyle Education (LE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 429 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2011to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1 essential hypertension, defined as a systolic blood pressure of 140-159 and/or DBP of 90-99 mmHg on two occasions at least 30 minutes apart.
- Women who are able to attend follow visits as advised.
Who cannot join
- Women with systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100 mmHg.
- Women who have other known causes of hypertension, such as renal diseases
- Women who are using sedatives or tranquilizer,or antidepressant, or antihypertensive medication during the past 2 months prior to the study.
- Have language or geographical barrier.
- Do not give their informed consent.
- Women who need to be prescribed HRT.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 3 Study of Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women
The purpose of this study is to demonstrate better effectiveness of modified relaxation (MR) technique over no MR for treating hypertension in Thai postmenopausal women.
Read the detailed description
Medical treatment of hypertension (HTN) in postmenopausal women is not very effective, as it requires co-operation and long-term commitment from the patients and their families. The medication itself may cause bothersome side effects and it can pose economic burden to the patients and the society. In contrast, lifestyle modifications, particularly relaxation technique, are less costly and relatively free of any side effects. Once the patients master the techniques, they can practice by themselves at home and at any time that is convenient to them. There is evidence from at least one RCT that the techniques are effective in reducing the systolic blood pressure (SBP) and diastolic blood pressure (DBP), even after a short practice of only two months.
In this study, the investigators propose a randomized control trial to examine the effectiveness of modified relaxation (MR) technique to control HTN in Thai postmenopausal women against a control group who practice no MR. Such a study in Thai population has not been done before. In addition, the investigators will extend the period of observation up to 16 weeks, to assess longer-term patients' compliance, and the effects of MR on BP.
- Conditions
- Postmenopausal Syndrome, Hypertension
- Being tested
- Modified Relaxation (MR), Lifestyle Education (LE)
- Keywords
- postmenopause, hypertension, relaxation, SBP 140-159 mmHg, DBP 90-99 mmHg, stage 1 or mild hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Relaxation (MR)Behavioural
Also called Behavioral Relaxation
Modified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period.
Lifestyle Education (LE)Behavioural
Also called Lifestyle Modification
Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle Education (LE) | Sham comparator | Lifestyle Education (LE) Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise. Receives: Behavioral: Lifestyle Education (LE) |
| Modified Relaxation (MR) | Experimental | Modified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period. Receives: Behavioral: Modified Relaxation (MR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in SBP.
Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months.
Measured: 16 weeks
Secondary outcomes (4)
Changes in DBP.
Measure the diastolic blood pressure (DBP) after intervention at 1, 2 ,3 , and 4 months.
Measured: 16 weeks
Continuation rate of MR practice.
Measure the continuation rate of MR practice after 4 months of follow-up period.
Measured: 16 weeks
Drop-out rates.
Measure the drop-out rate after intervention at 1, 2, 3, and 4 months of follow-up period.
Measured: 16 weeks
Numbers of subjects who require anti-hypertensive medication.
Measure the numbers of subjects who require anti-hypertensive medication after intervention 4 months of follow-up period.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postmenopausal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 429 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suprawita Saensak, Chiang Mai University
- Investigators
- Suprawita Saensak, PhDcandidate, Principal investigator, PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01429662
- Sponsor's protocol ID
- MRLE-HTN
- Status last verified
- May 2012
- First submitted
- 3 Sep 2011
- Last updated
- 30 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Saensak S, Vutyavanich T, Somboonporn W, Srisurapanont M. Modified relaxation technique for treating hypertension in Thai postmenopausal women. J Multidiscip Healthc. 2013 Oct 3;6:373-8. doi: 10.2147/JMDH.S51580. eCollection 2013.
PubMed 24124377
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Study of Modified Relaxation (MR) Technique for Treating Hypertension in Postmenopausal Women
- ClinicalTrials.gov ID
- NCT01429662
- Acronym / sponsor ID
- MRLE-HTN
- Conditions
- Postmenopausal Syndrome, Hypertension
- Keywords
- postmenopause, hypertension, relaxation, SBP 140-159 mmHg, DBP 90-99 mmHg, stage 1 or mild hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 429 participants (actual)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 7 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate better effectiveness of modified relaxation (MR) technique over no MR for treating hypertension in Thai postmenopausal women.
Detailed description
Medical treatment of hypertension (HTN) in postmenopausal women is not very effective, as it requires co-operation and long-term commitment from the patients and their families. The medication itself may cause bothersome side effects and it can pose economic burden to the patients and the society. In contrast, lifestyle modifications, particularly relaxation technique, are less costly and relatively free of any side effects. Once the patients master the techniques, they can practice by themselves at home and at any time that is convenient to them. There is evidence from at least one RCT that the techniques are effective in reducing the systolic blood pressure (SBP) and diastolic blood pressure (DBP), even after a short practice of only two months.
In this study, the investigators propose a randomized control trial to examine the effectiveness of modified relaxation (MR) technique to control HTN in Thai postmenopausal women against a control group who practice no MR. Such a study in Thai population has not been done before. In addition, the investigators will extend the period of observation up to 16 weeks, to assess longer-term patients' compliance, and the effects of MR on BP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle Education (LE) | Sham comparator | Behavioral: Lifestyle Education (LE)Lifestyle Education (LE) Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise. |
| Modified Relaxation (MR) | Experimental | Behavioral: Modified Relaxation (MR)Modified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Stage 1 essential hypertension, defined as a systolic blood pressure of 140-159 and/or DBP of 90-99 mmHg on two occasions at least 30 minutes apart.
- Women who are able to attend follow visits as advised.
Key exclusion criteria (6 listed)
- Women with systolic blood pressure (SBP) >160 mmHg or diastolic blood pressure (DBP) >100 mmHg.
- Women who have other known causes of hypertension, such as renal diseases
- Women who are using sedatives or tranquilizer,or antidepressant, or antihypertensive medication during the past 2 months prior to the study.
- Have language or geographical barrier.
- Do not give their informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Modified Relaxation (MR)Also: Behavioral RelaxationModified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period. | Behavioural | Modified Relaxation (MR) |
| Lifestyle Education (LE)Also: Lifestyle ModificationParticipants in this group will receive conventional care and lifestyle education on dietary choice and exercise. | Behavioural | Lifestyle Education (LE) |
Primary outcome
Changes in SBP.
Time frame: 16 weeks
Measure the systolic blood pressure (SBP) after intervention at 1, 2 ,3 , and 4 months.
4 secondary outcomes
Changes in DBP.
Time frame: 16 weeks
Continuation rate of MR practice.
Time frame: 16 weeks
Drop-out rates.
Time frame: 16 weeks
Numbers of subjects who require anti-hypertensive medication.
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2012.
- Derived from this study: PubMed 24124377Saensak S, Vutyavanich T, Somboonporn W, Srisurapanont M. Modified relaxation technique for treating hypertension in Thai postmenopausal women. J Multidiscip Healthc. 2013 Oct 3;6:373-8. doi: 10.2147/JMDH.S51580. eCollection 2013.
- NIH is the nation's medical research agency-supporting scientific studies that turn discovery into health.Link provided by the sponsor.
- PubMed comprises more than 21 million citations for biomedical literature from MEDLINE, life science journals, and online books.Link provided by the sponsor.
- The Journal of North American Menopause Society is a peer-reviewed scientific journal owned by NAMS and published by Lippincott Williams \& Wilkins (LWW).Link provided by the sponsor.
- The Journal of Behavioral Medicine is a broadly conceived interdisciplinary publication devoted to furthering understanding of physical health and illness through the knowledge and techniques of behavioral science.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suprawita Saensak, PhDcandidate principal investigator
PhD in Clinical Epidemiology Program, Faculty of Medicine, Chiang Mai University (Thailand)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modified Relaxation (MR) and Lifestyle Education (LE) in people with Postmenopausal Syndrome and Hypertension, run by Chiang Mai University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in SBP. (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01429662, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2012.